naltrexone hydrochloride

Generic: naltrexone hydrochloride

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naltrexone hydrochloride
Generic Name naltrexone hydrochloride
Labeler american health packaging
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

naltrexone hydrochloride 50 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-291
Product ID 68084-291_1ef27c71-786e-4f5e-e063-6294a90a7934
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076264
Listing Expiration 2026-12-31
Marketing Start 2013-06-03

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68084291
Hyphenated Format 68084-291

Supplemental Identifiers

RxCUI
1483744
UNII
Z6375YW9SF

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name naltrexone hydrochloride (source: ndc)
Generic Name naltrexone hydrochloride (source: ndc)
Application Number ANDA076264 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-291-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-291-11)
source: ndc

Packages (1)

68084-291-21 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-291-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-291-11)

Ingredients (1)

naltrexone hydrochloride (50 mg/1)

Linked Drug Pages (1)

NALTREXONE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1ef27c71-786e-4f5e-e063-6294a90a7934", "openfda": {"unii": ["Z6375YW9SF"], "rxcui": ["1483744"], "spl_set_id": ["81e25c6a-81b6-4cfb-91bf-be20c3ae546b"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-291-21)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-291-11)", "package_ndc": "68084-291-21", "marketing_start_date": "20130603"}], "brand_name": "NALTREXONE HYDROCHLORIDE", "product_id": "68084-291_1ef27c71-786e-4f5e-e063-6294a90a7934", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "68084-291", "generic_name": "naltrexone hydrochloride", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NALTREXONE HYDROCHLORIDE", "active_ingredients": [{"name": "NALTREXONE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA076264", "marketing_category": "ANDA", "marketing_start_date": "20130603", "listing_expiration_date": "20261231"}